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Acute Lymphoblastic LeukemiaPhase 2NCT00930098

A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

A Phase 2 study testing clofarabine in people with Acute Lymphoblastic Leukemia, run by Genzyme, a Sanofi Company at 36 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
clofarabine
How many people
74 participants
Where
36 sitesin 6 countries
Study dates
Dec 2003to Jul 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Have a diagnosis of ALL and confirmed by pathologic assessment.
  • Be ≤ 21 years old at time of initial diagnosis.
  • Eligible patients must have: Primary refractory disease; OR relapsed or refractory disease after a minimum of 2 prior blocks of treatment.
  • Must not be eligible for therapy of higher curative potential.
  • Have a Karnofsky Performance Status of ≥ 50 or Lansky Performance Scale of ≥ 30.
  • Provide a signed, written informed consent from parent or guardian or young adult patients.
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  • Be able to comply with study procedures and follow-up examinations.
  • Have adequate cardiac function without treatment.
  • Have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, AST and ALT, obtained within 7 days prior to registration.

Who cannot join

  • Received previous treatment with clofarabine.
  • Patients with isolated extramedullary disease.
  • Have received prior BMT or PBSCT within the last 6 months.
  • Have received prior BMT or PBSCT more than 6 months ago, but now has compromised organ function.
  • Have an active, uncontrolled systemic infection.
  • Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.
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  • Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
  • Have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.
  • Have any other severe concurrent disease.
  • Have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.
  • Have CNS disease.

Trial locations and contacts

36 sites in 6 countries.

36 sites in 6 countries

United Kingdom10 sites

  • Study site

    Birmingham

  • Study site

    Bristol

  • Study site

    Glasgow

  • Study site

    Leeds

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Newcastle upon Tyne

  • Study site

    Sheffield

  • Study site

    Sutton

Other trials in United Kingdom

France9 sites

  • Study site

    Besançon

  • Study site

    Bordeaux

  • Study site

    Lille

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Toulouse

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Germany9 sites

  • Study site

    Berlin

  • Study site

    Düsseldorf

  • Study site

    Frankfurt

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Kiel

  • Study site

    Munich

  • Study site

    Münster

  • Study site

    Stuttgart

Other trials in Germany

Netherlands5 sites

  • Study site

    Amsterdam

  • Study site

    Groningen

  • Study site

    Leiden

  • Study site

    Rotterdam

  • Study site

    Utrecht

Other trials in Netherlands

Italy2 sites

  • Study site

    Monza

  • Study site

    Pavia

Other trials in Italy

Austria1 site

  • Study site

    Vienna

Other trials in Austria

About this study

This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. It is a single arm study and has no comparator.

Read the detailed description

Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

Being tested
clofarabine
Keywords
acute lymphoblastic leukemia, clolar, evoltra, clofarabine, refractory/relapsed acute leukemia, pediatric acute leukemia
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clofarabineDrug

    Also called US Tradename = Clolar, EU Tradename = Evoltra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate after 1 course or more

    Measured: minimum of 1 course and maximum of 12 courses

Secondary outcomes (7)

  1. Overall response rate after 2 courses or more

    Measured: minimum of 2 courses and maximum of 12 courses

  2. Rate of response (complete, complete with incomplete blood count recovery, partial) after 1 course or more

    Measured: minimum of 1 course and maximum of 12 courses

  3. Time-to-event parameters including duration of remission and overall survival

    Measured: Until death of patient or until end of study treatment for last enrolled patient

  4. Safety and tolerability

    Measured: Until death of patient or until end of study treatment for last enrolled patient

  5. Number of patients received bone marrow or peripheral blood stem cell transplantation and the time to transplant following commencement of Clofarabine

    Measured: Until death of patient or until end of study treatment for last enrolled patient

  6. Determine pharmacokinetic profile and intracellular triphosphate and levels of clofarabine

    Measured: every day during the first course of treatment

  7. Document the metabolic pathways that may predict Clofarabine sensitivity or resistance

    Measured: day 1, day 5, day 6 and day 7 of the first course

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2009 (estimated)
  2. Study startDec 2003
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00930098
Sponsor's protocol ID
BIOV-111
Other IDs
UKCCSG: NAG 2003 06
Status last verified
Feb 2014
First submitted
17 Jun 2009
Last updated
11 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing clofarabine in people with Acute Lymphoblastic Leukemia, run by Genzyme, a Sanofi Company at 36 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United Kingdom, France, Germany, Netherlands, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate after 1 course or more (time frame: minimum of 1 course and maximum of 12 courses). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00930098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.

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